Detecting coatings on intraocular lens insertion devices and methods of manufacturing the devices

ABSTRACT

Methods for detecting a coating on a surface of an intraocular lens delivery device and methods of manufacturing the device are provided. A method includes forming the coating on the device, the coating including a lubricious-enhancing component and a fluorescing component, illuminating the fluorescing component to cause the fluorescing component to emit a glow, and determining characteristics of the coating on the device based on the glow of the fluorescing component.

FIELD OF THE INVENTION

The present invention relates in general to insertion devices fordelivering intraocular lenses into a patient's eye during visioncorrection surgery and, more particularly, to lens delivery cartridgesand methods of manufacturing cartridges.

BACKGROUND OF THE INVENTION

Cataract surgery is commonly performed on an eye in which an originallyclear, natural crystalline lens has become cloudy or opaque due tofactors such as aging, prolonged exposure to radiation, or certainmedical conditions. To provide vision correction to the affected eye, anartificial intraocular lens (IOL) is inserted adjacent or is used toreplace the natural crystalline lens. Typically, IOLs are made up of anoptically clear lens or “optic” that is secured in position within theeye via one or more flexible fixation members or “haptics”. The hapticsextend from the optic, and each haptic affixes directly to the eye.

Prior to surgery, the IOL is placed within an insertion deviceconfigured to deliver the IOL to the eye. In particular, the IOL ispositioned within a load chamber of a cartridge of the insertion device.The load chamber defines a first lumen for receiving the IOL so thatwhen the IOL is positioned therein, the cartridge may be manipulated tothereby roll, fold, or otherwise compress the IOL into a desired shape.An elongated inserter tube portion of the insertion device includes asecond, tapered lumen adjacent and in communication with the first lumenfor facilitating the passage of the folded IOL toward an exit of theinsertion tube.

During surgery, a small incision of about 1-4 mm is made in thepatient's eye. Preferably, the incision is as small as possible toreduce healing time. In some cases, a tool is inserted into the incisionto emulsify the patient's natural lens. The emulsified material is thenvacuum-suctioned from the eye. A tip of the insertion device is placedinto the incision and the IOL is urged into the first lumen to becompressed or folded. As the IOL travels from the first lumen to thesecond lumen of the elongated inserter tube, the IOL is furthercompressed, rolled or otherwise manipulated into smaller dimensionssuitable to pass through the 1-4 millimeter (mm) incision. The IOL thenslips into the eye through the incision and automatically unfoldstherein. In cases in which the natural lens remains in the eye, thefolded or compressed IOL is placed adjacent the natural lens.

To ensure that the IOL is intact post-delivery, the inner surfaces ofthe cartridge and the elongated inserter tube are coated with alubricity enhancing material to reduce an amount of force needed to passthe IOL through a small diameter of the insertion tube exit. Thoughdamage to the IOL is rare when passed through the insertion tube exit, amechanism to ensure lubricity of the cartridge's lumen and tip isadequate and uniform across the cartridge inner surface is desirable.

SUMMARY OF THE INVENTION

Methods for detecting a coating on a surface of a device are provided. Amethod includes forming the coating on the device, the coating includinga lubricious-enhancing component and a fluorescing component,illuminating the fluorescing component to cause the fluorescingcomponent to emit a glow, and determining characteristics of the coatingon the device based on the glow of the fluorescing component.

In another embodiment, a method of manufacturing an IOL insertion deviceincludes molding a cartridge of the insertion device, the cartridgehaving an inner surface defining a lumen for receiving an IOL, forming acoating on the inner surface of the cartridge, the coating including alubricious-enhancing material and a fluorescing compound, energizing thefluorescing compound in the coating to cause a light emission, andmeasuring the light emission to determine a characteristic of thecoating.

In another embodiment, an IOL device includes a molded cartridge havingan inner surface defining a lumen, and a coating disposed on the innersurface of the molded cartridge comprising a lubricious material and afluorescing compound.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the advantages of the invention will be readilyunderstood, a more particular description of the invention brieflydescribed above will be rendered by reference to specific embodimentsthat are illustrated in the appended drawings. Understanding that thesedrawings depict only typical embodiments of the invention and are nottherefore to be considered to be limiting of its scope, the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings, in which:

FIG. 1 is a perspective view of an intraocular lens (IOL) insertiondevice loaded onto a hand piece, according to an embodiment.

FIG. 2 is a perspective view of a cartridge in an open position andinserter tube for use with the IOL insertion device illustrated in FIG.1, according to an embodiment.

FIG. 3 is a perspective view of a cartridge in a closed position andinserter tube for use with the IOL insertion device illustrated in FIG.1, according to an embodiment.

FIG. 4 is a longitudinal cross section view of the cartridge andinserter tube illustrated in FIG. 3, according to an embodiment.

FIG. 5 is a close up of the cross section view of an inner surface ofthe cartridge and inserter tube illustrated in FIG. 4, according to anembodiment.

FIG. 6 is a flow diagram of a method of manufacturing an IOL insertiondevice, according to an embodiment.

FIG. 7 is a graph showing an increase in yellow index value as aconcentration of fluorescing compound increases.

FIG. 8 is a graph showing an increase in yellow index value as athickness of a coating including fluorescing compound therein increases.

DETAILED DESCRIPTION OF THE DRAWINGS

The following detailed description is merely exemplary in nature and isnot intended to limit the inventive subject matter or the applicationand uses of the inventive subject matter. Certain terminology may alsobe used in the following description for the purpose of reference only,and thus are not intended to be limiting. For example, terms such as“distal,” “proximal,” “inner,” “outer,” and “top” may refer to directionin the drawings to which reference is made and/or the orientation orlocation of portions of the components within a consistent but arbitraryframe of reference which is made clear by reference to the text and theassociated drawings describing the component under discussion. Suchterminology may include the words specifically mentioned above,derivatives thereof, and words of similar import.

Generally, the inventive subject matter is directed to intraocular lens(IOL) insertion devices, in particular, cartridges, and methods ofmanufacturing such devices. In an embodiment, the method includescoating an inner surface of the insertion device, where the innersurface defines a lumen for receiving an IOL. The coating includes alubricity-enhancing material and a fluorescent compound. Thelubricity-enhancing material minimizes friction between the IOL and theinner surface as the IOL passes through the lumen. The fluorescentcompound is used in subsequent steps to allow easy inspection of thequality of the coating. The coating is applied by spray, brush, dip orother methods. The fluorescent compound is energized to thereby emitlight, and the light emission is inspected. For example, the lightemission is measured, and a determination is made as to whether athickness or uniformity of the coating on the surface of the device isacceptable, based on the measurement of the light emission. If thethickness or uniformity is not acceptable, additional coating materialis applied to the device to form a thicker and/or more uniform coatingon the surface of the device.

With reference to FIGS. 1-4, various views of an intraocular lens (IOL)insertion device 100 and its components are provided. Insertion device100 is generally elongated and configured similar to a syringe. In anembodiment, insertion device 100 includes a main body 102, a cartridge104, and a plunger 106. Main body 102 is cylindrical and has openings108, 110 at distal and proximal ends, and a longitudinal cavity 112extending therebetween. Cavity 112 includes a plunger retention portion114 and a narrower cartridge receiving portion 116. Plunger retentionportion 114 is suitable in length for receiving at least a portion ofplunger 106 and to allow plunger 106 to travel therethrough. Plunger106, which is used to apply pressure on the IOL to thereby push the IOL118 (FIG. 3) through an end of cartridge 104 and out device 100,includes a rod 120 suitably sized and shaped for moving through cavity112 and into cartridge 104 to contact IOL 118, a retention body 122, anda handle 124 for a user to manipulate plunger 106. Retention body 122 isconfigured to be slid into plunger retention portion 114 and has adiameter larger than that of cartridge receiving portion 116. In anembodiment, one or both of the surfaces of retention body 122 and/orplunger retention portion 114 includes friction-enhancing components,such as a tacky substance or roughened surfaces, to provide addedcontrol for the user when the user applies pressure to handle 124.Distal opening 108, providing access into plunger retention portion 114,is larger in diameter than rod 120, but smaller in diameter than handle124 to allow handle 124 to remain outside of cavity 112 during operationof insertion device 100.

Main body 102 optionally includes a longitudinal opening 126 formedalong a portion of a length of cartridge receiving portion 116. Opening126 provides access to cavity 112 and is dimensioned to accommodate thesize and shape of cartridge 104. In an example, longitudinal opening 126has a distal portion 128 having a length and width that corresponds to alength and width of cartridge 104 so that cartridge 104 can beselectively inserted into and/or removed from main body 102 via opening126. A proximal portion 130 of opening 126 extending from distal portion128 is narrower in length and width than distal portion 128 so that, asexplained below, tabs 156, 158 of cartridge 104 can slide into and outof proximal portion 130 to thereby maintain cartridge 104 in a closedconfiguration during IOL delivery. Proximal opening 110 is configuredsuch that an insertion tip 134 of cartridge 104 extends a desired lengththerethrough. Alternatively, proximal opening 110 aligns with an opening136 at an end 138 of cartridge 104 to allow delivery of IOL 118 to adesired location.

As noted briefly above, cartridge 104 is configured to retain IOL 118.In this regard, cartridge 104 is generally tubular to define a firstlumen or load chamber 140 and a second lumen or delivery channel 142 forIOL 118 to traverse during an insertion process. Cartridge 104 has aloading portion 144 capable of being rotated between an openconfiguration (see, e.g., FIG. 2) for loading and a closed configuration(see, e.g., FIG. 3) for loading IOL 118 into load chamber 140. Aninsertion portion 146 extends longitudinally from loading portion 144 toreceive loaded IOL 118 when it travels from load chamber 140 to deliverychannel 142.

Loading portion 144 has two complimentary pieces 148, 150 each includinga grooved section 152, 154 and a tab section 156, 158. Grooved sections152, 154 are connected to each other along adjacent longitudinal edgesof grooved sections 152, 154. In an embodiment, the connection forms ahinge 160, which allows one of pieces 148 or 150 to be placed over thetop of the other one of pieces 148 or 150. Hinge 160 is integrallyformed as a semi-opaque seam between pieces 148, 150 or, alternatively,is a separate piece mounted between and connecting pieces 148, 150.

To form load chamber 140 when pieces 148, 150 are folded at hinge 160,grooved sections 152, 154 each includes substantially similarlyconfigured semicircular longitudinal channels, each channel forming onehalf of load chamber 140. A width of the two semicircular channels ispreferably is greater than a diameter of IOL 118 so that when IOL 118 ispositioned across the semicircular channels, IOL 118 folds over itselfas pieces 148, 150 are manipulated into the closed configuration. Tabsections 156, 158 extend from grooved sections 152, 154 away from hinge160 and are provided as gripping surfaces to allow a user to easilymanipulate pieces 148, 150 between the open and closed configurations.Although depicted as substantially rectangular, in other embodiments,tab sections 156, 158 are each semicircular, square, semiovular, oranother shape suitable for forming tabs that are sufficiently large suchthat the user avoids contacting interior surfaces of grooved sections152, 154. Additionally, although tab sections 156, 154 are shown assubstantially equal in size, one is larger than the other in alternateembodiments.

As noted previously, cartridge 104 includes insertion portion 146, whichreceives IOL 118 from load chamber 140 during the delivery process.Insertion portion 146 is connected to and extends from an edge definingan end of grooved sections 152, 154. To prevent contamination and damageto IOL 118 during delivery, insertion portion 146 is configured suchthat an opening into delivery channel 142 aligns with and issubstantially the same size as an opening into load chamber 140. In anembodiment, inner surfaces of load chamber 140 and delivery channel 142are substantially smooth to avoid inadvertently trapping IOL 118 withineither space. Outer surfaces of each of loading and insertion portions144, 146 are substantially smooth, except a seam 162 can be included ata location at which the two meet.

A proximal end of insertion portion 146 includes a tapered tube 164having a portion of delivery channel 142 formed therethrough. Accordingto an embodiment, delivery channel 142 is also tapered and has anincreasingly smaller diameter such that proximal opening 136 oninsertion tip 134 has a diameter suitable for delivering IOL 118 into apatient's eye through an incision having a length in a range of about 1millimeters (mm) to about 5 mm, and more preferably in a range of lessthan about 2 mm. In this regard, insertion tip 134 preferably has adiameter that is less than the aforementioned ranges.

To ensure smooth delivery of IOL 118 and to reduce a likelihood ofdamage thereto, cartridge 104 is formed from materials capable ofwithstanding high frictional forces during the IOL 118 delivery process.Suitable materials for cartridge 104 include, but are not limited to,materials having a characteristic toughness that allows >150% elongationor strain without damaging the polymer (e.g., cracking or ripping), forexample between about 150% and about 500%, or between about 250% and600%. Further, the polymeric materials have tensile strengthspreferably >1000 psi, such as between about 1000 psi and about 10,000psi, or about 5000 psi and 8000 psi.

Cartridge 104 is formed from hydrophilic or hydrophobic polymers with ahardness greater than about 50 D, preferably between about 50 D andabout 85 D. In an embodiment, cartridge 104 is formed from an aromaticpolyurethane with a hardness of between about 55 D and about 75 D, forexample the Pellethane, Tecothane, Texin, and Esthane families ofaromatic polyurethane. Alternatively, cartridge 104 is formed fromaliphatic polyurethane with a hardness between about 60 D and about 72D, for example Tecoflex. It is also noted that the “D” numbers providedabove are measures of hardness. Specifically, the numbers provided aboveindicate the Shore (Durometer) hardness of the material, which isbasically a measure of the material's resistance to indentation. Thenumbers do not directly measure the material's toughness. However,polymeric materials are commonly identified by their Shore hardness, andthe materials identified above have favorable toughness. Materialexhibiting one or more of the aforementioned properties include, but arenot limited to polyurethane polymers; polyethylene, polypropylene,styrene related copolymers, such as but not limited to, acrylicbutyldiene styrene (ABS), styrene butyldiene styrene (SBS), and/or highimpact polystyrene (HIPS); polyester polymers; and polymeric blends orcopolymers thereof.

Polyurethane polymers may have a number of different compositions. Forinstance, particular polyurethanes may be aromatic or aliphatic and maybe hydrophilic or hydrophobic. Such polyurethanes may have differentmechanical properties, such as but not limited to toughnesscharacteristics, other physical properties, and other surfaceproperties. Further regarding physical properties of polymeric materialsdescribed herein whether they be solids, gels, fluids, liquids or thelike, hydrophobic polymeric materials generally have toughnesscharacteristics and hydrophilic polymeric materials generally havelubricious characteristics. These characteristics are by no meanslimiting, but exemplary.

To reduce the likelihood of damage to IOL 118 during delivery and toensure lubricity of delivery channel 142, selected portions of cartridge104 include a coating 168, as illustrated in FIG. 5. For example, acoating 168 is disposed on inner surfaces of cartridge 104, such as onsurfaces defining delivery channel 142, and on insertion tip 134.Coating 168 is formed from materials including a lubricious-enhancingcomponent and a fluorescing component or fluorescing compound. Thelubricious-enhancing component includes materials havingcharacteristics, including but not limited to one or more hydrophilicpolymeric material, such as hydrophilic polyurethane,polyvinylpyrrolidone, polyacrylic acid, polyacrylamides,polyhydroxyethyl methacrylate, polyethylene oxide, polyethylene glycoland/or hyaluronan, or the like.

The hydrophilic polymeric material contains reactive groups orsubstituents that allow at least limited covalent attachment tocartridge 104, in an embodiment. For example, the hydrophilic materialmay be applied to cartridge 104 as a precursor material and hence,includes substituent groups effective to enhance the stability, forexample the storage stability or shelf life, of cartridge 104 relativeto an identical cartridge including a lubricity enhancing componentwithout the substituent groups. Preferably, the substituent groups areeffective to reduce hydrolysis of the lubricity enhancing coatingrelative to an identical lubricity enhancing coating or componentwithout the substituent groups. In an embodiment, the substituent groupsare not —OH groups, that is, are non-hydroxy groups. For instance, thesubstituent component may be selected from the class consisting ofhydrocarbyl groups, substituted hydrocarbyl groups, and mixturesthereof, preferably such groups having 1 to about 4 carbon atoms pergroup. In another embodiment, the substituent component is selected fromalkoxy groups, preferably alkoxy groups having 1 to about 4 carbon atomsper group, and mixtures thereof. In still another embodiment, thesubstituent component includes one or more methoxy groups.

According to an embodiment, the lubricity-enhancing component is derivedfrom a hydrophilic, water soluble precursor component or materialincluding the aforementioned substituent component or groups, analkylene oxide component and the reactive substituent component orgroups effective to covalently bond with the substrate (i.e., thepolymeric material of cartridge 104). Such reactive groups, or at leasta portion of such reactive groups, are effective to form homopolymers ofthe precursor material. The alkylene oxide component, for example, inthe form of a polyalkylene glycol component and the like, may beselected from, for example, ethylene oxide components, propylene oxidecomponents, and the like, and mixtures thereof. The alkylene oxidecomponent is preferably an ethylene oxide component, for example apolyethylene glycol component. The reactive substituent component orgroups are preferably selected from ethylenically unsaturated groups,and are more preferably selected from vinyl groups, acrylic groups,methacrylic groups, and the like, and mixtures thereof. In anembodiment, the precursor material of the lubricity enhancing componentis a hydrophilic, water soluble acrylic-based monomer such as methoxypolyethylene glycol monomethacrylate (mPEGMA) of similar or differingmolecular weights. In an another embodiment, the precursor material ofthe lubricity enhancing component is a hydrophilic, water solubleurethane-based polymer such as ether linkage and ester linkagepolyurethane.

The fluorescing component is a material that is capable of emitting aglow and that does not adversely affect the stability of coating 168.Suitable materials for use as the fluorescing compound include, but arenot limited to, biocompatible fluorescing compounds such as fluorescein,sodium salts and/or derivatives of fluorescein, and the like. Coating168 also includes a crosslinking agent, such as polyfunctionalaziridine, polyfunctional carbodiimide, isocyanate, and the like.

FIG. 6 is a flow diagram of a method 600 of forming cartridge 104. In anembodiment, cartridge 104 is molded using a suitably configured mold at602. Cartridge 104 is molded as a single piece of material and/or ismade from a blend of two or more different ones of the above mentionedmaterials. Alternatively, different portions of cartridge 104, forexample, loading portion 144 and insertion portion 146 are formed asseparate components from one or more materials and are welded, adhered,coupled, or otherwise joined together. Alternatively, cartridge 104 iscomolded from two or more materials that are extruded and/or injectionmolded to form a single piece to thereby yield a component havingdifferent physical properties at different locations thereon.

A coating 168 is formed in insertion portion 146 of cartridge 104 at604. In particular, coating 168 is formed over an inner surface ofcartridge 104 defining delivery channel 142 and over a surface ofinsertion tip 134. In an embodiment, insertion portion 146 is formedfrom lubricious-enhancing and fluorescing material and co-molded withthe remainder of cartridge 104. In another embodiment, the fluorescingmaterial and one or more of the lubricious materials described above isused to form a lubricious coating over the selected surfaces ofcartridge 104 by brushing, spraying or otherwise applying a thin layerof the materials on the selected surfaces of cartridge 104. For example,a dispersion is formed from the fluorescing material, thelubricious-enhancing material, and a cross-linking agent. In anembodiment, a suitable amount of fluorescing compound, such as an amountsuitable for forming between about 0.1% to about 5% dry concentration offluorescing material in dry dispersion, is dissolved in water to formsolution. Substantially equal amounts of the lubricious-enhancingcomponent and a crosslinking agent are added to the fluorescing compoundsolution to form the dispersion including the about 0.1% to about 5% dryconcentration of fluorescing material.

Optionally, prior to receiving the dispersion, the inner surfaces ofcartridge 104, in particular, those surfaces on which coating 168 is tobe applied, are treated with plasma to enhance adhesion of coating 168thereto. In an embodiment, cartridge 104 is exposed to plasma for asuitable duration to prime surfaces of delivery channel 142. The plasmais derived from one or more gases, including but not limited to oxygen,helium, nitrogen, argon, nitrous oxide, carbon dioxide and the like, andis delivered via a PS-150 plasma unit or another suitable plasmadelivery device. The plasma includes oxygen at a flow rate of 20 cc/minand argon at a flow rate of 10 cc/min. The duration of treatment isabout 5 minutes.

The dispersion is applied to cartridge 104 via brush application, sprayapplication, injecting the solution into delivery channel 142, dippingcartridge 104 into the solution including the fluorescing compound, orany other suitable application method.

According to an embodiment in which the dispersion is applied tocartridge 104 as a precursor material, cartridge 104, and morespecifically, insertion portion 146 of cartridge 104, is prepared forreceiving the precursor material. After plasma treatment, the dispersionis applied to a wall of cartridge 104, for instance by spraying,brushing, immersion, irrigation, or the like. The coated, or wetted,wall is then exposed to conditions effective to cause the precursormaterial in the dispersion to form a lubricity enhancing component, orcoating, having covalent bonds with the polymeric material of the tube.Subsequently, the wetted wall is post-cured at conditions effective toform coating 168 and to enhance the stability thereof.

In an embodiment, the precursor material includes radical initiators,for instance UV and/or thermal radical initiators. The step of causingthe precursor material to form a covalently bonded lubricity enhancingcomponent preferably includes exposing the wetted wall to conditionssuitable for activating the initiator or initiators. In an embodiment inwhich the precursor material includes both UV and thermal radicalinitiators, the step of exposing the wetted wall to conditions suitablefor activating the initiator or initiators includes a first stage ofexposing the wetted wall to ultraviolet light to form a covalentlybonded coating 168 on the interior wall, and a second stage of exposingthe covalently bonded coating 168 on the wall to elevated temperaturesfor a time sufficient to enhance the stability of the covalently bondedcoating 168. After coating 168 has been exposed to the UV light and/orelevated temperatures, unreacted monomers are removed from cartridge 104surface, for instance by washing. Any suitable UV initiator and/orthermal initiator may be employed provided such materials have nosubstantial detrimental effect on the inserter, on the IOL to beinserted or on the patient in whose eye the IOL is inserted.

Next, the quality of coating 168 is assessed at 606. Energy is providedto the fluorescing compound to cause the fluorescing compound to emit aglow. Ultraviolet (UV) light is directed at cartridge 104 to energizethe fluorescing compound. For example, a UV lamp or other device capableof emitting light within a UV wavelength range (e.g., 100 nanometers(nm) to 600 nm) is powered on and when the UV light interacts with thefluorescing compound, electrons in the fluorescing compound excitecausing the compound to emit light or a glow. Measurements of theresulting glow intensity are obtained using a light measuring device,such as a handheld photodetector, a lux meter or other type of lightmeter configured to detect the intensity of the light emitted across asurface of cartridge 104 (including surfaces of coating 168).

The intensity of the glow can be affected by factors such as theconcentration of the fluorescing compound present in coating 168, theintensity of the UV light used to excite the fluorescing compound, thethickness of coating 168 within which the fluorescing compound isdisposed, and/or the uniformity of coating 168. Hence, such factors canbe used to determine the characteristics of coating 168. In an example,a particular concentration of the fluorescing compound for inclusion incoating 168 is selected, coating 168 is formed, and UV light of adesired intensity is directed at coating 168. The intensity of theemitted glow is measured and compared to reference values. For instance,using measurements taken from a reference location on coating 168 asreference values, light intensity measurements obtained from otherlocations on coating 168 are compared to the reference values todetermine thickness of coating 168. In particular, those light intensitymeasurement values greater than the reference values indicate areas ofcoating 168 having a greater thickness than the reference location,while light intensity measurement values that are less than thereference values indicate areas of coating 168 that are thinner than thereference location. Alternatively or additionally, the thickness ofcoating 168 can be determined by comparing the measurements of the lightemitted by the excited fluorescing compound in coating 168 to a visiblelight of yellow index. To measure the color of the light emitted, aspectrophotometer, such as an Ultrascan PRO™ provided by HunterAssociates Laboratory, Inc. of Reston, Va., or another instrumentcapable of measuring visible color is used. A higher yellow index valueindicates a greater thickness of coating 168. To determine theuniformity of coating 168, light intensity measurements acrosssubstantially an entirety of coating 168 are obtained and adetermination is made as to whether the measurements fall within aparticular range.

If the values obtained above indicate either a uniformity or thicknessof coating 168 that is less than desirable, coating 168 is deemedunacceptable. Accordingly, cartridge 104 is returned to manufacturing tobe re-coated at 604. If the values indicating the uniformity orthickness of coating 168 are equal to or exceed the correspondingreference values, the coating 168 is deemed acceptable and method 600ends.

The following examples are presented to illustrate aspects and featuresof various embodiments of the present inventive subject matter, and arenot to be taken as limiting the inventive subject matter in any respect.

Example 1

Cartridges formed from polypropylene were obtained and surfaces thereof,in particular, inner surfaces forming delivery channels, were treatedwith plasma. The cartridges then were coated with dispersions offluorescein.

Specifically, cartridges were each coated with dispersions includingconcentrations of about 5.0%, 1.0%, and 0.5% dry weight of fluorescein.To form a dispersion including a concentration of about 5.0% dry weightof fluorescein, about 0.490 gram (g) of fluorescein sodium salt wasweighed and placed in a 100 milliliter (mL) propylene bottle, and about50.02 g of polyurethane dispersion (solid content about 20%) and about0.50 g of polyfunctional aziridine was added to the same bottle andcapped. For a concentration of about 1.0% dry weight of fluorescein,about 0.1083 g of a sodium salt of fluorescein was weighed and placed ina 100 mL polypropylene bottle, and an amount of polyurethane dispersion(solid content about 20%) weighing about 51.94 g and about 0.50 g ofpolyfunctional aziridine were placed in the same bottle and capped. Fora dispersion including a concentration of about 0.5% dry weight offluorescein, about 0.049 g of a sodium salt of fluorescein was weighedand placed in a 100 mL polypropylene bottle, and an amount ofpolyurethane dispersion (solid content about 20%) weighing about 51.65 gand about 0.50 g of polyfunctional aziridine were placed in the samebottle and capped. Each bottle was placed on a stir plate and eachdispersion was mixed for about 15 minutes using a stir bar. Thedispersions were delivered into the delivery channels of correspondingcartridges via a plastic pipette until a meniscus formed in the deliverychannel. The dispersions were allowed to run out of the cartridges viagravity. The cartridges were placed in a centrifuge to spin-off remnantsof the dispersions and subsequently placed on a hot plate at about 60°Celsius (C) for about 10 minutes to dry.

Other cartridges were coated with dispersions including concentrationsof 0.1% and 0.05% dry weight of fluorescein. The dispersion includingthe concentration of 0.1% dry weight of fluorescein was formed byweighing a sodium salt of fluorescein in an amount of about 0.1070 g andplacing the fluorescein sodium salt into a tube containing 10 mL of purewater. The tube was shaken until all of the fluorescein sodium saltdissolved into the water. An amount of a polyurethane dispersion (solidcontent about 20%) weighing about 51.34 g and about 0.50 g ofpolyfunctional aziridine were placed in a 100 mL polypropylene bottle.About 1 mL of the fluorescein sodium salt solution was added to thebottle, and the bottle was capped. The dispersion including theconcentration of 0.05% dry weight of fluorescein was formed by weighinga sodium salt of fluorescein in an amount of about 0.018 g and placingthe fluorescein sodium salt into a tube containing about 10 g of purewater. The tube was shaken until all of the fluorescein sodium saltdissolved into the water. An amount of a polyurethane dispersion (solidcontent about 20%) weighing about 49.87 g and about 0.50 g ofpolyfunctional aziridine were placed in a 100 mL polypropylene bottle.About 2.73 g of the fluorescein sodium salt solution was added to thebottle, and the bottle was capped.

Each bottle was placed on a Vortex mixer and shaken. A plastic pipettewas used to deliver the dispersions into the delivery channels ofcorresponding cartridges until a meniscus formed in the deliverychannels. The dispersions were allowed to run out of the cartridge viagravity. A vacuum was used to remove any dispersion remaining on thecartridge, and the cartridges were then placed in a vacuum oven at about60° Celsius (C) for about 10 minutes to dry.

Example 2

Each cartridge was explored using an ultraviolet lamp at 254 nanometer(nm) and 365 nm wavelengths. As shown in Table 1, fluorescein wasdetected on all of the cartridges except those coated with 0.05% dryweight concentration of the fluorescein dispersion. Non-coated portionsof the cartridges did not fluoresce.

TABLE 1 % dry concentration of fluorescein in dry dispersion 5 1 0.5 0.10.05 Flurorescein detected shine shine shine shine no shine by UV 254 nm& 365 nm

Example 3

The coated cartridges including concentrations of about 5.0%, 1.0%,0.5%, and 0.1% dry weight of fluorescein of Example 1 and uncoatedcartridges were placed in a tray and a UV lamp emitting UV light at awavelength of 325 nm was directed at the tray. The coated cartridgesemitted a glow, while the uncoated cartridges did not. Cartridges coatedwith the higher concentration of dispersion (e.g., 1% dry weightconcentration) emitted a brighter light than those coated with the lowerconcentration of dispersion. Additionally, those portions of the coatedcartridges having thicker coatings, for example, the tips of the coatedcartridges, appeared to be brighter than those portions having thinnercoatings. Since coating uniformity is required, the cartridges havingthicker portions were rejected.

Example 4

The yellow index was measured for cartridges including concentrations ofabout 1.0%, 0.5%, and 0.1% dry weight of fluorescein. The yellow indexvalues were measured by employing an UltraScan PRO chromameter sold byHunter Associate Laboratory of Reston, Va. FIG. 7 is a graph 700plotting the measured results. In particular, graph 700 includes ay-axis including yellow index values in a range of from 0.00 to 18.00and an x-axis including dry weight concentration of the measuredcartridge. Plot line 702 shows the yellow index value increases as thedry weight concentration of the fluorescein in the coating of thecartridge increases.

Example 5

To determine whether thickness of coating 168 could be detected, theyellow index for different coating thicknesses were measured. Three 43mm aluminum pans were used and solutions of about 2.01 g, about 1.10 g,and about 0.22 g of the 0.1% dry weight concentration of the fluoresceinsodium salt dispersion were poured into respective pans. Each pan wasdried at room temperature overnight and then placed in an oven at 110°C. for one hour. The pans were cooled to room temperature and eachresulting film was peeled from the pans. The thickness of each film wasmeasured using a micrometer device and the yellow index of each wasmeasured using the UltraScan PRO chromameter. Another set of three filmswas prepared in a similar manner as described previously, except a 0.5%dry weight concentration of the fluorescein sodium salt dispersion wasused. Lastly, a third set of three films was also prepared in a similarmanner as described previously, except a 1% dry weight concentration ofthe fluorescein sodium salt dispersion was used.

FIG. 8 is a graph 800 showing the resulting measurements obtained fromthe testing conducted above and from measurements taken from cartridgesincluding concentrations of about 1.0%, 0.5%, and 0.1% dry weight offluorescein formed in Example 1. Plot lines 802, 804, and 806 eachinitiate on the left at plots of the measurements taken from cartridgesincluding concentrations of about 1.0%, 0.5%, and 0.1% dry weight offluorescein formed in Example 1. The remaining measurements from thetesting described above are plotted to the right of the aforementionedplots. Each of the plot lines 802, 804 and 806 generally shows that asthickness of the coating increases, the yellow index measurementincreases as well. Additionally, the yellow index measurements aregreater for films having higher concentrations of fluorescein sodiumsalt.

By using relatively small amounts (e.g., about 0.1% to about 5.0% dryweight concentration) of fluorescein, or another biocompatiblefluorescing compound, the quality of lubricious coatings on cartridgescan be easily, quickly, and safely ascertained. The fluorescein remainson the cartridge during lens delivery, thus minimizing potentialirritation experienced by a patient's eye.

While at least one exemplary embodiment has been presented in theforegoing detailed description of the inventive subject matter, itshould be appreciated that a vast number of variations exist. It shouldalso be appreciated that the exemplary embodiment or exemplaryembodiments are only examples, and are not intended to limit the scope,applicability, or configuration of the inventive subject matter in anyway. Rather, the foregoing detailed description will provide thoseskilled in the art with a convenient road map for implementing anexemplary embodiment of the inventive subject matter. It beingunderstood that various changes may be made in the function andarrangement of elements described in an exemplary embodiment withoutdeparting from the scope of the inventive subject matter as set forth inthe appended claims.

What is claimed is:
 1. A method of detecting a characteristic of acoating on a surface of an intraocular lens delivery device comprising:forming the coating on the device, the coating including alubricious-enhancing component and a fluorescing component; illuminatingthe fluorescing component to cause the fluorescing component to emit aglow; and determining characteristics of the coating on the device basedon the glow of the fluorescing component.
 2. The method of claim 1,wherein the lubricious-enhancing component comprises a hydrophilicpolymeric material.
 3. The method of claim 1, wherein the fluorescingcomponent comprises fluorescein.
 4. The method of claim 1, whereinforming the coating includes forming a dispersion including aconcentration of about 0.01% to about 5.0% of the fluorescing componentin the coating and applying the dispersion to the device.
 5. The methodof claim 4, wherein forming the coating further comprises mixing thefluorescing component with the lubricious-enhancing component and acrosslinking agent to form the dispersion.
 6. The method of claim 1,wherein the device comprises an intraocular lens (IOL) cartridge and thesurface comprises an inner surface of the IOL cartridge defining a lumenfor receiving an IOL.
 7. The method of claim 1, further comprisingcomparing the glow of the fluorescing component to a reference anddetermining a thickness of the coating based on the comparison.
 8. Themethod of claim 7, further comprising applying another layer of coatingmaterial to the coating, if the thickness of the coating determined bythe comparison is below the reference.
 9. The method of claim 1, furthercomprising comparing the glow of the fluorescing component to areference and determining a uniformity of the coating over the surfaceof the device based on the comparison.
 10. The method of claim 1,wherein comparing the glow of the fluorescing component to a referenceincludes obtaining a measurement of a color of the glow of thefluorescing component with a hand-held photodetector, and comparing themeasurement of the color to a yellow index table to determine athickness of the coating.
 11. A method of manufacturing an intraocularlens (IOL) insertion device comprising: molding a cartridge of theinsertion device, the cartridge having an inner surface defining a lumenfor receiving the IOL; forming a coating on the inner surface of thecartridge, the coating including a lubricious-enhancing material and afluorescing compound; energizing the fluorescing compound in the coatingto cause a light emission; and measuring the light emission to determinea characteristic of the coating.
 12. The method of claim 11, furthercomprising applying another layer of coating to the inner surface of thecartridge, if a measurement of an intensity of the light emission isbelow a reference value.
 13. The method of claim 11, further comprisingexposing the inner surface of the cartridge to plasma to wet the innersurface, prior to forming the coating.
 14. The method of claim 13,wherein the lubricious-enhancing material includes thermal radicalinitiators and ultraviolet radical initiators, and forming the coatingincludes exposing the lubricious-enhancing material to ultraviolet lightand to elevated temperatures for a time sufficient to enhance stabilityof a resultant covalently bonded coating formed on the inner surface ofthe cartridge.
 15. The method of claim 11, wherein the measuring thelight emission includes measuring a color of the light emission andcomparing the color to a yellow index to determine a thickness of thecoating.
 16. The method of claim 11, wherein the fluorescing compoundcomprises fluorescein.
 17. The method of claim 11, wherein the coatingincludes a crosslinking agent.
 18. The method of claim 11, furthercomprising determining a uniformity of the coating over the innersurface of the cartridge, based on a measurement of an intensity of thelight emission.
 19. An intraocular lens (IOL) insertion devicecomprising: a molded cartridge having an inner surface defining a lumen;and a coating disposed on the inner surface of the molded cartridgecomprising a lubricious material and a fluorescing compound.
 20. The IOLinsertion device of claim 19, wherein the molded cartridge comprisespolypropylene.
 21. The IOL insertion device of claim 19, wherein thelubricious material is covalently bonded to the inner surface of themolded cartridge and includes a thermal radical initiator and anultraviolet radical initiator.
 22. The IOL insertion device of claim 19,wherein the fluorescing compound comprises a sodium salt of fluorescein.23. The IOL insertion device of claim 19, wherein the coating includes aconcentration of about 0.1% to about 5.0% dry weight of the fluorescingcompound.
 24. The IOL insertion device of claim 19, wherein the coatingincludes a crosslinking agent.